A Phase 1 interventional study of LY3454738 and LY3454738 in Dermatitis, Atopic, sponsored by Eli Lilly and Company. Completed at 21 sites in 2 countries. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-10-06.
Sponsored by Eli Lilly and Company · Phase 1, Interventional, and Treatment
The main purpose of this study is to investigate the safety, tolerability, and efficacy of the study drug known as LY3454738 in healthy participants and participants with atopic dermatitis. The study has three parts. Each participant will enroll in one part. The study will last 12 to 24 weeks, depending on part.
1,443 studies on the registry are indexed under Dermatitis, Atopic; 253 are open to participants now.
This study's enrollment of 128 is above the median of 83 across 1,143 interventional studies indexed under Dermatitis, Atopic.
Browse Dermatitis, Atopic studies →Eli Lilly and Company is the lead sponsor of 2,095 studies on the registry; 142 are open to participants now.
Of its 535 completed or terminated interventional studies of FDA-regulated products, 356 (67%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
AD:
Exclusion Criteria:
AD:
Escalating doses of LY3454738 administered intravenously (IV) or subcutaneously (SC) to healthy participants
Drug: LY3454738
Placebo administered IV to healthy participants
Drug: Placebo
LY3454738 administered IV to healthy participants
Drug: LY3454738
Placebo administered IV to healthy participants
Drug: Placebo
LY3454738 administered IV to participants with atopic dermatitis (AD)
Drug: LY3454738
Placebo administered IV to participants with AD
Drug: Placebo
Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration
A summary of SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module
Time frame: Baseline up to Week 24
Number of Participants Achieving a Validated Investigator's Global Assessment for Atopic Dermatitis (vIGA-AD) Score of 0 or 1 with a ≥ 2-point Improvement from Baseline
The vIGA-AD measures the investigator's global assessment of the participant's overall severity of their AD, based on a static, numeric 5-point scale from 0 (clear skin) to 4 (severe disease). The score is based on an overall assessment of the degree of erythema, papulation/induration, oozing/crusting, and lichenification
Time frame: Week 12
Maximum Observed Drug Concentration (Cmax) of LY3454738
Cmax of LY3454738
Time frame: Day 1 through Day 85 (Day 99 for Part C)
Area Under the Concentration-Versus-Time Curve (AUC) of LY3454738
AUC of LY3454738
Time frame: Day 1 through Day 85 (Day 99 for Part C)
Plan to share: No
Ran from Nov 2018 to primary completion in Sep 2021, 33 months.
Of 98 industry-sponsored phase 1 interventional studies under Dermatitis, Atopic, half reached primary completion within 13 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 21. This study's 33 months is above that.
Counting every sponsor, half of 116 studies reached it within 14 months; a quarter within 6 and three quarters within 21.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Oct 2021. You cannot join it, but the record below documents what was studied.
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